ANDA 079198

MYLAN INSTITUTIONAL

FDA Drug Application

Application #079198

Application Sponsors

ANDA 079198

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 0.05MG BASE/ML	0	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE
002	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML	0	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE
003	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	0	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE

FDA Submissions

	ORIG	1	AP	2011-02-10
LABELING; Labeling	SUPPL	2	AP	2011-12-02
LABELING; Labeling	SUPPL	3	AP	2013-05-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-07-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-07-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-09-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79198
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"OCTREOTIDE ACETATE (PRESERVATIVE FREE)","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 0.05MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OCTREOTIDE ACETATE (PRESERVATIVE FREE)","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 0.1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OCTREOTIDE ACETATE (PRESERVATIVE FREE)","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 0.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OCTREOTIDE ACETATE (PRESERVATIVE FREE)","submission":"OCTREOTIDE ACETATE","actionType":"EQ 0.05MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OCTREOTIDE ACETATE (PRESERVATIVE FREE)","submission":"OCTREOTIDE ACETATE","actionType":"EQ 0.1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OCTREOTIDE ACETATE (PRESERVATIVE FREE)","submission":"OCTREOTIDE ACETATE","actionType":"EQ 0.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)